From Alarms to Batch Release

The customer

A leading biotechnology company specialising in the development and production of innovative active ingredients based on mRNA technology. Their focus lies on vaccines and personalised therapies.

Background & initial situation

• The manufacturing of pharmaceutical products is subject to strict regulations (keyword: GMP).

• This includes, among other things, the monitoring and review of alarms and operator messages. An alarm is triggered whenever a process deviation occurs (for example, deviations in temperature, cleanroom pressure, etc.).

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  In addition, there are operator messages (=AuditTrail), which occur when a process parameter is changed by an operator.

• All alarms, operator messages, and batch data are fully recorded.

   

• The shift supervisor is responsible for reviewing alarms and operator messages, assessing their potential impact on the product, and—depending on the evaluation—approving or blocking the batch.

• For reporting, alarms and operator messages had to be manually compiled.

Approach & solution

Objective: Automated report generation with RtReports. Authorised personnel can comment on, verify, and then release the report in a two-stage approval process.

• To achieve this, we connected the PI data (alarms, operator messages, and batch data) to AVEVA RtReports and configured the reports in line with customer requirements.
• We began by gathering the various requirements and, on this basis, created report templates for the different production areas.
• Thanks to the integration with the PI System, these data could be directly used in RtReports.
• Reports are automatically linked to production batches.
• hey can be accessed, reviewed, commented on, and electronically signed by staff. All signatures comply with 21 CFR Part 11. Audit readiness is ensured since the reports are accessible at any time to authorised personnel.
• In addition, the solution meets the requirements of the EU GMP Annex 11 for computerised systems.
• All reports underwent a formal validation process, including the creation of documentation, test plans, and reports:
  • Functional specifications (FS)
  • Installation qualification plan (IQ plan)
  • Operational qualifictation plan (OQ plan)
  • Installation qualification report (IQ report)
  • Operational qualifictation report (OQ report)

Results & benefits

Alarms and operator messages are now automatically categorised and clearly presented in a report. These reports are a central element of the batch release process and significantly streamline and accelerate it—eliminating the need for manual compilation and time-consuming cross-checking against production periods.

Since batch data are also directly linked to the reports, traceability has been greatly improved, making batch reviews simpler and more reliable.

Added benefit: In the case of an audit, these reports can also be retrieved retrospectively and used as proof. The automated reports ensure the customer is audit-ready at all times.

Overall, teams gain more time for value-adding tasks, processes become more reliable, and batch release achieves greater quality and traceability.